Testing ANSOS for Efficacy in Multi-Tribal Urban Communities
NCT ID: NCT06566703
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
384 participants
INTERVENTIONAL
2023-08-18
2026-08-18
Brief Summary
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Detailed Description
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Group Support Sessions: The primary component of ANSOS are four group-based support sessions, led by an AI facilitator, conducted via Zoom. All group sessions begin with team building and discussion about things people are experiencing in their lives, both those related directly to recreational tobacco use and other things that help or hinder quit attempts. The first group session is devoted to forming a cohesive group and learning about individual journeys with tobacco. Additional group sessions focus on topics covered in the education curriculum.
Individual Telephone Counseling: After initial group sessions, facilitators call participants weekly to see how they are doing, discuss personal issues related to the quitting process, and to remind them of the next group.
Educational Curriculum: The ANSOS curriculum includes 11 brochures, given throughout the program; it combines cessation information with cultural elements. Topics covered include substantial information about tobacco as a sacred plant for many, though not all, AI tribes, historical trauma, and medical/research mistrust issues, among other topics related to how to effectively quit using recreational tobacco products. Educational materials for this project will be given to participants electronically via pdf documents.
Healthy Living is an educational program primarily designed to maintain the interest of participants in the control arm in continuing into the ANSOS program after their 6-month waiting period. It includes group-based educational discussion about healthy diet, exercise, and stress management, along with educational materials on these topics. Participants also receive individual discussion with program facilitators in between group sessions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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All Nation Snuff Out Smokeless
This is a culturally targeted smokeless tobacco cessation program developed for American Indian communities. It includes group sessions via Zoom, individual telephone counseling, and educational materials.
All Nations Snuff Out Smokeless
All Nations Snuff Out Smokeless is a culturally tailored smokeless tobacco cessation program that incorporates group-based and individual counseling.
Healthy Living
Healthy Living is an educational program that provides information about diet, exercise, stress, and general health. It uses group-based and individual discussion, along with educational materials.
Wait List Control - Healthy Living
Participants randomized to this arm are provided with information about healthy living while they wait for their turn at the intervention arm. Participants learn about diet, exercise, and stress reduction. They receive the All Nations Snuff Out Smokeless intervention after a six-month waiting period.
All Nations Snuff Out Smokeless
All Nations Snuff Out Smokeless is a culturally tailored smokeless tobacco cessation program that incorporates group-based and individual counseling.
Healthy Living
Healthy Living is an educational program that provides information about diet, exercise, stress, and general health. It uses group-based and individual discussion, along with educational materials.
Interventions
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All Nations Snuff Out Smokeless
All Nations Snuff Out Smokeless is a culturally tailored smokeless tobacco cessation program that incorporates group-based and individual counseling.
Healthy Living
Healthy Living is an educational program that provides information about diet, exercise, stress, and general health. It uses group-based and individual discussion, along with educational materials.
Eligibility Criteria
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Inclusion Criteria
* Stable telephone number that can be used for the purpose of the study
* Willing to be followed for 12 months and participate in study activities
* Able to attend Zoom sessions
* Current SLT user, at least once per day
* Self-reported AI
Exclusion Criteria
* Unable to attend Zoom sessions
18 Years
ALL
Yes
Sponsors
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American Cancer Society, Inc.
OTHER
Lehigh University
OTHER
Responsible Party
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Principal Investigators
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Christine M Daley, PhD
Role: PRINCIPAL_INVESTIGATOR
Lehigh University
Locations
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Lehigh University
Bethlehem, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RSG-21-043-01-CPPB
Identifier Type: -
Identifier Source: org_study_id
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